The approval metrics look very similar to previous months during this fiscal year but there is good news on the number of new original ANDAs received. Let’s take a look! The OGD approved 56 ANDAs in March, 7 of which were first-time generics and 17 (30%) were approved in the first cycle. This 30% represents […]
The number of approval actions that were posted for the first half of April 2026 might be a record. The FDA issued 59 full-approval actions (helped a great deal by full approvals of 24 ANDAs and 5 tentative approvals on April 6th for Dapagliflozin single entity and combination products on the day of the expiration of the […]
We posted a blog earlier today (here) regarding the FDA’s announcement that it plans to review a number of drug substances at a two-day meeting, in July, of the Pharmacy Compounding Advisory Committee. Later in the day, the FDA released a document outlining additional plans to reclassify other drug substances, including several peptide drug substances, […]
The FDA has announced a two-day meeting of the Pharmacy Compounding Advisory Committee for the purpose of reviewing certain bulk drug substances nominated for inclusion in the Section 503A bulk drug substances list. The meeting is scheduled for July 23-24, 2026, and it will be held at the FDA’s White Oak Campus. The full notice from the […]
In a post on the FDA Law Blog (here), Kurt Karst, Director, Hyman Phelps & McNamara, did a masterful job of outlining some of the FDA budget legislative proposals for 2027. I’ve known Kurt for a very long time, and we usually agree on most topics; however, his take on one of the elements appearing […]
A few months before the end of 2025, the FDA requested that Glaxo Smith-Kline (GSK) revise its approved labeling by submitting a supplemental application to its Wellcovorin (leucovorin calcium) to include an indication for cerebral folate deficiency (CFD), a rare disorder. This came after Secretary Kennedy’s thus far unsuccessful hunt for the cause of autism. […]
On Tuesday, April 7th, the FDA announced that the Office of Generic Drugs had approved multiple first generics for Dapagloflozin Tablets. A quick review of the listings for the product in the Orange Book shows that there were a total of fifteen ANDAs approved on Monday, April 6th, which was the first business day that the FDA […]
There’s always a certain energy at PDA Week – the kind that comes from a shared sense that our industry is moving, sometimes faster than we expect. This year in Denver, that energy felt different. More focused. More urgent. And in many ways, more practical. As both an exhibitor and attendee representing Lachman Consultants, I […]
The FDA has posted a total of 82 approval actions in March to date on the FDA All Approvals page. Of course, these numbers could change over the next few days as the posting of some applications is delayed. The OGD’s approval pace has been consistent over the past eighteen months. During March, the OGD […]
Today, FDA approved Lilly’s GLP-1 oral tablet as the first approval of a new molecular entity (NME) through the CNPV program. The FDA says the drug Foundayo (orforglipron), “was approved 50 days after the NDA was filed and 294 days before the application’s PDUFA date of January 20, 2027”. According to the FDA (here), commissioner […]
